Fixation device for securing a linear element to a workpiece

ABSTRACT

A fixation device for securing a linear element to a workpiece includes a contact component and a fixation component. The contact component typically includes (i) a first contact surface for application to a workpiece and (ii) a first opening for receiving a linear element. The fixation component typically secures a portion of the linear element on a side of the first contact component opposite the first contact surface. The fixation component engages the contact component to prevent passage of the linear element&#39;s secured portion through the workpiece when a tension is applied to the linear element in a direction opposite the contact surface.

CROSS-REFERENCE TO PRIORITY APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 14/706,572 for Fixation Device for Securing a Linear Element toa Workpiece filed May 7, 2015 (and published Aug. 27, 2015, as PatentApplication Publication No. US 2015/0240852), which claims the benefitof International Application No. PCT/US2013/069467 for a Fixation Devicefor Securing a Linear Element to a Workpiece filed Nov. 11, 2013 (andpublished May 22, 2014 as WIPO Publication No. WO 2014/078237), whichclaims the benefit of U.S. Patent Application No. 61/727,373 for aFixation Device for Securing a Linear Element to a Workpiece (filed Nov.16, 2012) and U.S. Patent Application No. 61/787,062 for a FixationDevice for Securing a Linear Element to a Workpiece (filed Mar. 15,2013). Each of the foregoing patent applications and patent publicationsis incorporated herein by reference in its entirety.

BACKGROUND

Generally speaking, there is a need for fixation of linear elements thatpass through a perforation in a work piece in many industrial,construction, and/or medical applications as well as other activities.Linear elements can include rigid structures (e.g., rods and/or dowels)and flexible (e.g., cord-like) structures (e.g., ropes, cables, sutures,wires, etc.).

In some instances, the forces which act upon the linear element only actin a single direction. An example of such would be the suspension of afixture or decorative element that travels through the ceiling with aclamping device on the upper surface of the ceiling. In this example,the weight of the fixture and connecting wire produce a downward forcewhich is transferred to the clamping device which is subsequentlypressed downward against the upper surface of the ceiling. In otherwords, the fixation device provides a single force vector resistance.

In other instances, such as in a metallic support rod in construction,the fixation needs to prevent the rod from moving toward or away fromthe workpiece (e.g., a beam). In other words, the fixation deviceprovides a juxtaposed force vector resistance.

A device that is easily placed over a linear element and has strongfixation to the linear element can perform this task alone in the firstinstance (i.e., single force vector resistance), and when such a deviceis secured to the work piece can stabilize in the second instance(juxtaposed force vector resistance).

The placement of surgical sutures to close a skin wound provides aprototypical example of how a device that secures a linear element to awork piece may change the workflow and results compared to other methodsof fixation. In traditional suture methods a needle with attached sutureis passed sequentially through both sides of a wound, and then the“free” suture end (opposite the needle) is tied to a section of thesuture strand between the needle and the free end to form a loop.

The problem with this method is that the tissues may not be ideallyeverted for optimal healing and the portion of the suture strand thatlies over the surface of the skin can cause trauma and ultimatelyproduce scars lying horizontal to the direction of the wound itself. Inaddition, removal of sutures can be uncomfortable as scissor tips needto be passed between the skin surface and the suture loop, placingadditional tension on the sutures.

On the other hand, the placement of surgical sutures to the skin bymeans of surgical buttons eliminates the loop entirely and thepossibility of horizontal scarring. If the free end of the suture (i.e.,the end opposite the needle) is secured with a flat object (e.g., asurgical button, suture clip, or similar device) and the needle ispassed through tissue, then the object is brought into contact with theskin on the object's flat surface as the suture is advanced, preventingthe suture from passing all the way through the tissue and transferringany force on the suture to the skin. If a second button is secured tothe suture on the opposite side of a wound, under appropriate tension,the wound is brought into contact and held there in a stable fashion.The suture strand may be cut and then reused. In traditionalmanifestations, surgical buttons and/or suture clips have beenrelatively cumbersome to use and, therefore, have not achievedwidespread, common usage.

Therefore, a need exists for a fixation device that provides a flatsurface for the transfer of tension in a linear element to a broadsurface of the workpiece and facilitates simple and easy fixation andswift deployment.

SUMMARY

Accordingly, in one aspect, the present invention embraces a fixationdevice for securing a linear element to a workpiece that includes afirst contact component and a first fixation component. The firstcontact component has a first contact surface for application to aworkpiece and a first opening for receiving a linear element. The firstfixation component secures a portion of the linear element on a side ofthe first contact component opposite the first contact surface. Thefirst fixation component engages the first contact component to preventpassage of the linear element's secured portion through the workpiecewhen a tension is applied to the linear element in a direction oppositethe first contact surface.

In an exemplary embodiment, the fixation device also includes a secondcontact component and a second fixation component. The second contactcomponent has a second contact surface for application to a workpieceand a second opening for receiving a linear element. The second fixationcomponent secures a portion of the linear element on a side of thesecond contact component opposite the second contact surface. The secondfixation component engages the second contact component to preventpassage of the linear element's secured portion through the workpiecewhen a tension is applied to the linear element in a direction oppositethe second contact surface. Typically, the first fixation component andthe second fixation component are positioned between the first contactcomponent and the second contact component.

In another exemplary embodiment, the first contact component and thefirst fixation component are physically connected.

In yet another exemplary embodiment, the second contact component andthe second fixation component are physically connected.

In yet another exemplary embodiment, as measured in a plane parallel tothe contact surface, the fixation device's cross sectional area at thearea of engagement between the contact component and the fixationcomponent is smaller than (i) the contact component's average crosssectional area and (ii) the fixation component's average cross sectionalarea.

In yet another exemplary embodiment, the exterior surface of thefixation device opposite the contact surface primarily includes smoothsurfaces.

In yet another exemplary embodiment, the ratio of (i) the height of thefixation device as measured from the contact surface to the end of thefixation component opposite the contact surface to (ii) the maximumwidth of the contact surface is approximately one or less.

In yet another exemplary embodiment, the contact component's openingincludes a hole.

In yet another exemplary embodiment, the contact component's openingincludes a groove.

In yet another exemplary embodiment, the fixation component includes anadhesive.

In yet another exemplary embodiment, the fixation component includes ajagged surface for engaging the linear element.

In yet another exemplary embodiment, the fixation device is made of amaterial that is capable of being deformed using tools powered only byaverage human hand strength.

In yet another exemplary embodiment, the contact component's contactsurface includes an adhesive, medication, and/or padding.

The foregoing illustrative summary, as well as other exemplaryobjectives and/or advantages of the invention, and the manner in whichthe same are accomplished, are further explained within the followingdetailed description and its accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1D depict an exemplary embodiment of a bi-directional fixationdevice in accordance with the present invention.

FIG. 1E depicts another exemplary embodiment of a bi-directionalfixation device in accordance with the present invention.

FIGS. 2A-2F depict an exemplary method of using another exemplaryembodiment of a bi-directional fixation device and an exemplaryapplicator device in accordance with the present invention.

FIG. 3A depicts another exemplary embodiment of a bi-directionalfixation device in accordance with the present invention.

FIG. 3B depicts another exemplary embodiment of a bi-directionalfixation device in accordance with the present invention.

FIGS. 3C-3D depict another exemplary embodiment of a bi-directionalfixation device in accordance with the present invention.

FIG. 3E depicts another exemplary embodiment of a bi-directionalfixation device in accordance with the present invention.

FIG. 3F depicts another exemplary embodiment of a bi-directionalfixation device in accordance with the present invention.

FIG. 4A depicts another exemplary method of using another exemplaryembodiment of a bi-directional fixation device and another exemplaryapplicator device in accordance with the present invention.

FIG. 4B depicts the exemplary embodiment of a bi-directional fixationdevice of FIG. 4A.

FIG. 4C depicts a portion of the exemplary embodiment of abi-directional fixation device of FIG. 4A.

FIGS. 4D-4E depict another exemplary method of using another exemplaryembodiment of a bi-directional fixation device and another exemplaryapplicator device in accordance with the present invention.

FIG. 5A depicts an exemplary fixation device in accordance with thepresent invention.

FIG. 5B depicts another exemplary embodiment of a bi-directionalfixation device in accordance with the present invention.

FIG. 5C depicts another exemplary fixation device in accordance with thepresent invention.

FIGS. 5D and 5E depict an exemplary method of using another exemplaryfixation device in accordance with the present invention.

FIG. 5F depicts another exemplary method of using another exemplaryfixation device in accordance with the present invention.

FIG. 6 depicts another exemplary embodiment of a bi-directional fixationdevice in accordance with the present invention.

FIG. 7A depicts another exemplary fixation device in accordance with thepresent invention.

FIGS. 7B-7E depict another exemplary method of using another exemplaryfixation device and an exemplary removal tool in accordance with thepresent invention.

FIGS. 8A-8C, 9A, 9B, and 10 depict another exemplary method of usinganother exemplary fixation device in accordance with the presentinvention.

FIGS. 11A-11C depict another exemplary method of using another exemplaryfixation device in accordance with the present invention.

FIGS. 12A-12D depict another exemplary method of using another exemplaryembodiment of a bi-directional fixation device and another exemplaryapplicator device in accordance with the present invention.

FIG. 13A depicts another exemplary fixation device in accordance withthe present invention.

FIGS. 13B-13G depict another exemplary method of using another exemplaryfixation device in accordance with the present invention.

FIGS. 14A-14E depict another exemplary method of using another exemplaryembodiment of a bi-directional fixation device and another exemplaryapplicator device in accordance with the present invention.

FIGS. 15A-15D depict another exemplary method of using another exemplaryfixation device and an exemplary removal tool in accordance with thepresent invention.

FIG. 16A depicts another exemplary fixation device in accordance withthe present invention.

FIGS. 16B and 16C depict another exemplary fixation device in accordancewith the present invention.

FIG. 16D depicts another exemplary fixation device in accordance withthe present invention.

FIG. 16E depicts another exemplary fixation device in accordance withthe present invention.

FIG. 17A depicts another exemplary fixation device in accordance withthe present invention.

FIG. 17B depicts another exemplary fixation device in accordance withthe present invention.

FIG. 18A depicts another exemplary fixation device in accordance withthe present invention.

FIGS. 18B-18D depict another exemplary method of using another exemplaryfixation device in accordance with the present invention.

FIG. 19A depicts another exemplary fixation device in accordance withthe present invention.

FIGS. 19B and 19C depict close-up views of exemplary interlockingelements included in exemplary fixation devices in accordance with thepresent invention.

FIG. 19D depicts another exemplary fixation device in accordance withthe present invention.

FIGS. 19E and 19F depict exemplary interlocking elements included inexemplary fixation devices in accordance with the present invention.

FIGS. 20A-20C depict another exemplary method of using another exemplaryfixation device in accordance with the present invention.

FIGS. 20D and 20E depict another exemplary method of using anotherexemplary fixation device in accordance with the present invention.

FIGS. 21A-21D depict another exemplary method of using another exemplaryfixation device and another exemplary application device in accordancewith the present invention.

FIG. 22A depicts another exemplary fixation device in accordance withthe present invention.

FIG. 22B depicts an exemplary fixation component of an exemplaryfixation device in accordance with the present invention.

FIGS. 22C and 22D depict another exemplary method of using anotherexemplary fixation device and another exemplary application device inaccordance with the present invention.

FIGS. 23A-23D depict another exemplary method of using another exemplaryfixation device and another exemplary application device in accordancewith the present invention.

DETAILED DESCRIPTION

The present invention embraces a fixation device that provides a flatsurface for the transfer of tension in a linear element to a broadsurface of a workpiece and facilitates simple and easy fixation andswift deployment. In exemplary embodiments, the fixation device isformed of materials such as deformable polymers and supplementaryadhesives. An exemplary fixation device is bi-directional and can beapplied in either direction. In other words, the fixation deviceincludes two halves that are mirror-images of each other.

In exemplary embodiments, the fixation device includes a fixationcomponent that secures the linear element that is readily removed fromthe other component(s) of the fixation device. Typically, the fixationcomponent can be removed without increasing the tension on the linearelement. When the linear element is a suture, such embodimentsfacilitate the removal of the suture and reduce the pain experienced bythe patient.

FIGS. 1A-1E depict exemplary embodiments of a bi-directional fixationdevice 100 in accordance with the present invention. The bi-directionalfixation device is composed of two distinct fixation devices oriented inopposite directions along the longitudinal axis as defined by the mostcentral point of the tunnel, channel, or groove exhibited (i.e., thefirst opening 103 and the second opening 107). As depicted, the leftportion of the fixation device 100 includes a first contact component101 having a first contact surface 102 for application to a workpieceand a first opening 103 for receiving a linear element. The left portionof the fixation device 100 also includes a first fixation component 104for securing a portion of the linear element on the side of the firstcontact component 101 opposite the first contact surface 102.

The right portion of the fixation device 100 includes a second contactcomponent 105 having a second contact surface 106 for application to aworkpiece and a second opening 107 for receiving a linear element. Theright portion of the fixation device 100 also includes a second fixationcomponent 108 for securing a portion of the linear element on a side ofthe second contact component 105 opposite the second contact surface106.

As depicted, the fixation device's left and right portions arephysically connected at medial joint 109. Furthermore, the first contactcomponent 101 and first fixation component 104 are physically connected.The second contact component 105 and the second fixation component 108are also physically connected. That said, each of these portions andcomponents may be physically separate from each other.

FIG. 1B depicts an exemplary embodiment of the fixation device 100 thata first opening 103 and a second opening 107 that form a closed tunnel,rather than the channel or groove depicted in FIGS. 1C and 1D.

As depicted, the composite device 100 has symmetrical individualfixation components, but other exemplary devices may includeasymmetrical components. Furthermore the two component fixation devicescan be physically separate or can be formed as a single composite unit.Upon activation which secures the linear element within each of the twocomponent fixation devices, the component fixation devices can beseparated and function independently. In this embodiment, eachindividual component fixation device demonstrates a lateral (orterminal) section (i.e., the first contact component 101 or the secondcontact component 105) that is typically wider than a central (ormedial) section (e.g., the first fixation component 104 or secondfixation component 108). The central (or medial) section is so designedthat it can be activated to restrain a linear element within the groove,notch, channel, or tunnel to a degree that is required for usage. Insome cases, the lateral section may also undergo a change inconfiguration or other change that assists in this function. Althougheither an individual (component) fixation device or a composite,bi-directional device may be formed of a single material, in otherinstances the central (medial) and lateral (terminal) sections can becomposed of different materials.

FIGS. 2A-2F depict an exemplary method of using an exemplary embodimentof a bi-directional fixation device 100 in accordance with the presentinvention. FIGS. 2A-2B depict how a bi-directional fixation device 100can first be applied to a linear element 40, herein demonstrating theexample of a suture with a needle 41. The same principle can be appliedto any linear element 40, either rigid or cord-like. The linear element40 being fixed is positioned within the common channel, groove, ortunnel of the bi-directional fixation device 100 in a position along thelongitudinal axis of the linear element 40.

As depicted in FIGS. 2C-2D, the bidirectional device 100 is thenactivated so that the linear element 40 is firmly held by the fixationdevice 100. In this embodiment this fixation is by means of anapplicator device 50 that deforms a malleable or deformable centralsection (e.g., the first fixation component 104, the second fixationcomponent 108, and the medial joint 109), thus constricting the sides ofthe channel, groove, or tunnel of the central section against thecontained linear element 40. (See FIG. 2D). The applicator device 50thus functions as a crimper.

Furthermore, the applicator device 50 demonstrates specific featuresthat enable this function, including surfaces to contract the body ofthe central (medial) section, a cutting element to divide thebi-directional fixation device 100 into the two component fixationdevices after activation (See FIGS. 2E and 2F), and surface features tohelp hold, orient, or deploy the device 100. The applicator device 50can be mechanically activated by manual pressure, pneumatic, electrical,or other means. In addition, the applicator device 50 may be designed todeploy either a single (component) fixation device, two physicallyseparate (component) fixation devices so oriented as to function as asingle bi-directional fixation device, and/or a bi-directional fixationdevice. In addition, the applicator device 50 may be of a single-loaddesign, with new fixation devices loaded individually after eachdeployment, or may be a multi-load device, wherein new fixation devicesare advanced into the deployment position by the applicator device 50.The applicator device 50 may be designed as an endoscopic instrument.

FIGS. 3A-3F depicts multiple exemplary embodiments of a fixation device100 in accordance with the present invention and features thereof. Thefixation device can have numerous shapes, material compositions, colors,profiles, or other characteristics. The central (medial, apical) section(i.e., the first fixation component 104, the second fixation component108, and/or the medial joint 109) may have a smooth and/or high profile(e.g., to provide greater channel area for fixation) as shown, forexample, in FIGS. 3C-3E. The central section may also have a lowerprofile (e.g., as shown in FIG. 3A) creating a smooth contour both aloneand in conjunction with the lateral (terminal, contact) sections (i.e.,the first contact component 101 and second contact component 105).

FIG. 3B depicts an exemplary embodiment of a fixation device 100 havinglateral (terminal, contact) sections and medial (central, fixation)sections that are physically separate structures. The central sectioncan assume the form of a clip as shown in the upper portion of FIG. 3B.

The central sections can have a relatively straight configuration priorto deployment or can exhibit grooves, notches, flattened surfaces,holes, textures, bulges or other surface features to aid in positioning,alignment, securing, application, removal or function of the fixationdevice. Similarly, the lateral (terminal, contact) section may exhibitcontour variations such as holes, notches, grooves, textures, flattenedsurfaces, or other surface features to aid in positioning, alignment,securing, application, removal, or function of the fixation device. Forexample, FIG. 3E depicts an exemplary fixation device 100 that includesa contact surface 102 having a cupped contour to improve the interfacebetween the fixation device and a workpiece. FIG. 3F depicts an overheadview of an exemplary fixation component having flat sides to facilitatealignment of a fixation device 100 within an applicator device 50. Suchfeatures may interact with contours exhibited by applicator devices ormay accommodate features of the surface to which the fixation device isin contact before, during, or after deployment.

FIGS. 4A-4C depict exemplary methods of using an exemplary embodiment ofa fixation device 100 and an exemplary embodiment of an applicatordevice 50 in accordance with the present invention. As depicted,deformation of the central section (e.g., the first fixation component104, the second fixation component 108, and the medial joint 109) occursby a bending motion of the central section at approximately 90 degreesin relation to the longitudinal axis of a component (single) fixationdevice or bi-directional device. The bending also compresses the centralsection to constrict the tunnel, groove, or notch containing the linearelement 40 and can position the deformed central section against thelateral (contact, terminal) section (i.e., the first contact component101 or the second contact component 105) to reduce device height. Seee.g., FIGS. 5C-5F. In addition, the lateral section in this embodimentcan exhibit a groove, notch, or depression to accept the deformedcentral section. See e.g., FIGS. 5C-5F. The central section can be soconstructed that a hole, window, or groove (i.e., access opening 110) ispresent at the transition zone where the bend angle is of greatestacuity, thus providing access to the contained linear element. See e.g.,FIGS. 5C-5F. The access opening 110 allows the contained linear element40 to be divided without separation of the central section from thelateral section. Other fixation means for facilitating fixation of thelinear element 40 within the fixation device 100 may be employed,including heat application, integrated or applied adhesives (e.g.,pressure sensitive adhesives, cyanoacrylates, etc.), light activation,mechanical activation (e.g., ultrasonic energy), pins, wedges, screws,posts, interlocking components or other means. The central section canbe composed of material with inherent adhesive properties.

FIGS. 5A-6 depict multiple exemplary embodiments of a fixation device100 in accordance with the present invention and features thereof. Asdepicted in FIG. 5A, the central section (e.g., the first fixationcomponent 104) and the lateral section (e.g., the first contactcomponent 101) can be designed to connect at a transition zone 111 thatis of a lesser width (in relationship to the longitudinal axis definedby the central channel, tunnel, or groove) than both the central andlateral sections. The transition zone 111 facilitates positioning and/orsecuring the fixation device 100 within an applicator, storagecontainer, applicator-loading, or other device. The transition zone 111can also facilitate separation of the central and lateral sections ifsuch separation is desired, as in removal of the fixation device 100from a workpiece.

As depicted in FIG. 6, the central channel, groove, or tunnel canexhibit striations, transverse grooves, textures, adhesives, waves, orother features to help secure the linear element 40 within the fixationdevice 100. These features may be confined to the lateral section,medial section, or to both sections.

The lateral section can be so configured to accommodate the centralsection during deployment as depicted in FIGS. 5D and 5E. In addition,the dimensions of the accommodating feature in the lateral section canbe configured to have a lesser width than that of the central section,thereby providing a compressive force against the central section whenthe central section is positioned within the accommodating feature ofthe lateral section as depicted in FIG. 5F.

The contact surface of the lateral (terminal, contact) section (i.e.,the first contact component or the second contact component), typicallythe surface opposite the central section, can exhibit adhesives,medicaments, padding, absorbent materials, or other features to enhanceuse. For example, having a silicone coating on the contact surface mayimprove the function of the fixation device when it is in contact withthe skin or tissue when the linear element is a suture. The central(medial) section can similarly exhibit features such as slots, grooves,notches, and/or surface features, that may function to assist insecuring, deploying, or removing the fixation device or that may be usedas secondary fixation points (e.g., for securing additional structuresto the fixation device).

FIGS. 7A-7E depict an exemplary method of using an exemplary embodimentof a fixation device 100 and an exemplary embodiment of a removal tool60 in accordance with the present invention. FIG. 7A depicts a fixationdevice 100 that includes a flexible fixation component 104 that deformsto allow the removal tool 60 to slide between the fixation component 104and the contact component 101. FIG. 7B depicts a fixation device 100having a narrow transition zone 111 between the fixation component 104and contact component 101 to allow the removal tool 60 to slide betweenthe fixation component 104 and the contact component 101.

FIG. 7C depicts a linear element 40 secured to a workpiece 70 (e.g., apatient's skin) by two fixation devices 100 each having a contactcomponent 101, a fixation component 102, and a narrow transition zone111. A removal tool 60 is positioned over one of the fixation devices100. In FIG. 7D, the removal tool has engaged and cut through thetransition zone 111 and the linear element 40, thereby disconnecting thefixation component 102 from the contact component 101. Furthermore, thelinear element 40 in FIG. 7D is only secured to the fixation device 100on the right. FIG. 7E depicts the removal of the fixation device 100 onthe right, along with the linear element 40, from the workpiece 70 andthe removal of the contact component 101 from the workpiece 70.

Once deployed (i.e., secured to a workpiece), the fixation device 100can be removed by a variety of methods, including release of the central(fixation) section, separation of the central section from the lateral(contact) section, unbending, untwisting, or unscrewing the centralsection from the lateral section, repositioning pins or other fixationstructures, dividing the linear element at a point between the zone oflinear element fixation and the contact surface of the lateral section,or dividing the linear element at a point between the contact surface ofthe lateral section and the surface with which it interfaces. The linearelement can be released by removing the central section. The releaseremoval of the central section can be partial or complete, depending onthe number, size, and position of the attachments between the centralsection and the lateral section (i.e., the transition zone). Forexample, if the central section is in two or more physically separatesections and the removal force divides the attachment between onecomponent of the central section and the lateral section, a portion(s)of the central section may remain intact as the linear element isreleased.

Removal of the central section from the lateral section can also includedivision of the linear element at a point between the central sectionand the lateral section (i.e., the transition zone), thus releasing thelinear element concurrently with the central section.

In another exemplary embodiment, the central section or transition zonecan include a hole, window, groove, or other feature that allows thelinear element to be accessed and cut within the transition zone withoutremoving the central section from the lateral section. The liner elementcould be cut using scissors, a knife, a scalpel, or a special cuttinginstrument specifically designed to efficiently interact and bepositioned over the fixation device. Additionally, an embodiment of adevice to separate the central section from the lateral section caninclude a chamber or space in which the divided central section iscaptured upon separation from the lateral section at the transitionzone.

FIGS. 7A-7E also demonstrate an embodiment of the fixation devicewherein the overall composite shape of the central section and thelateral section, as deployed, assumes a smooth, low profile contour.Such a contour would provide potential benefits to the fixation device,such as reducing the chance that external forces could act upon ordisplace the fixation device. As an example, if the fixation device wasin the form of a surgical button used to secure a suture through theskin, such a low profile would reduce the chance that the device will behit, rubbed, or impacted in such a way that it could temporarilydisplace the fixation device and thus cause a patient pain or cause harmto a healing wound.

In yet a further method of use, if the linear element is an absorbablesurgical suture material, the natural process of suture breakdown, e.g.,hydrolysis, will proceed without user intervention. At the point in timethat the suture lacks sufficient tensile strength to maintain structuralintegrity, both fixation devices will be released and may fall outspontaneously, or may be potentially wiped off the tissue surface,obviating the need for any specific suture or fixation device removal.

FIGS. 8A-10 depict an exemplary method of using an exemplary embodimentof a fixation device 100 in accordance with the present invention. Usingthe bi-directional fixation device 100, a cycle is created where thedeployment of the bi-directional fixation device simultaneouslycompletes the second part of a first two part linear element functionand “pre-loads” a single component fixation device, properly oriented,on the linear element, thus completing the first part of the second twopart linear fixation function.

FIGS. 8A-10 depict the placement of surgical sutures for exemplarypurposes, but the principles of the method and device function wouldapply to other bi-directional fixation devices with either rigid orcord-like linear elements. At the start of the cycle depicted in FIG.8A, a component fixation device 100 including a contact component 101and fixation component 104 is attached to the free end of the suture 40.The fixation device 100 is oriented such that the contact component'scontact surface 102, i.e., the surface opposite the fixation component104, is closer in proximity to the suture needle 41 than the centralsection (i.e., the fixation component 104). The needle 41 is passedthrough the tissues as would typically be done to approximate the woundmargins. See FIGS. 8A-8C. As the needle 41 emerges from the tissue andthe suture 40 (i.e., the linear element) is advanced, the contactsurface of the lateral section (i.e., contact component 101) of thefirst fixation device 100 is brought in contact with the skin, and withadditional tension on the suture the wound margins are brought intoappropriate alignment. See FIG. 9A. While this tension and approximationare maintained, a bi-directional fixation device 100 is positioned suchthat the suture 40 emerging from the tissue on the side of the defectopposite the component fixation device that is already attached lieswithin the central channel, groove, or slot of the bi-directionalfixation device 100. While this position of the suture 40 within thebi-directional fixation device 100 is maintained, the contact surface102 of one component lateral section (i.e., contact component 101) ofthe bi-directional fixation device 100 is brought into position againstthe second surface of the tissue. See FIG. 9B.

An applicator, which may have been used to hold and align thebi-directional fixation device 100), is activated to secure the suture40 within the first fixation component 105 and the second fixationcomponent 108. The activation of the applicator also separates the firstfixation component 105 from the second fixation component 108 and cutsthe suture 40. See FIG. 10.

With the completion of deployment, the wound remains in proximity withboth ends of the divided suture secured within component fixationdevices on both sides of the wound, and a component fixation device ispre-loaded and appropriately oriented for initiation of the next cycle.In other words, the suture 40, needle 41, and second, detached half ofthe fixation device 100 depicted in FIG. 10 can be used to initiateanother wound approximation as depicted in FIG. 8A.

Because deployment of the bi-directional fixation device simultaneouslycompletes the second half of one two-part fixation function and thefirst half of a second two-part fixation function, the placement offixation devices becomes quicker and more efficient. In addition,because the linear element is divided immediately adjacent to the apexof the central section, there is essentially no waste of linear elementlength, thereby allowing greater utilization of the linear element as afunction of length. As an example, use of the fixation device as asurgical button maximizes the number of individual wound approximationsthat can be achieved with a single suture-needle combination.

FIG. 11A depicts a side view of an exemplary fixation device 100, andFIG. 11B depicts an overhead view of the same exemplary fixation device100. The fixation device 100 includes a contact component 101 having anopening 103 and a fixation component 104. The fixation device 100 alsoincludes a transition zone 111 joining the contact component 101 andfixation component 104. The depicted transition zone 111 includes postsor rods connecting the contact component 101 and fixation component 104.

Exemplary embodiments of a fixation device in accordance with thepresent invention may include a central (medial) section connected tothe lateral (contact, terminal) section by a transition zone that iselongated, septate, or discontinuous. For example, the transition zonecan exhibit the form of posts or rods that connect the central sectionto the lateral section, potentially functioning both as a “spacer” toincrease the distance between the lateral and central sections, but alsofacilitating function of the device.

FIG. 11B depicts transition zone connections 111 a and 111 b that areoffset in relationship to the common channel, groove, of slot of thefixation device 100. The portion of the central section (i.e., thefixation component 104) which is attached to the lateral section (i.e.,contact component 101) by the transition zone connections 111 a and 111b remains stable during the application of a deforming, deploymentforce, while the portion of the fixation component 104 that is notattached to the contact component 101 is mobile in relationship to thecommon channel, groove, or slot.

The exemplary embodiment of FIG. 11B includes a contact component 101having a post, pin, rod, or other surface feature (e.g., locking pin112) that interfaces with a hole, slot, groove, or other surface featureon another portion of the contact component 101 such that the featuresinterlock, connect, or secure the contact component 101 as they areapproximated. By altering the attachments between the lateral section(i.e., contact component 101) and the central section (i.e., thefixation component 104), the central section can also rotate or pivot inrelationship to the lateral section, thus securing a linear element tothe fixation device.

FIGS. 12A-12D depict exemplary methods of using an exemplary fixationdevice 100 and an exemplary applicator device 50 in accordance with thepresent invention. Either a single component fixation device, twophysically separate component fixation devices applied simultaneously,or a bi-directional fixation device can exhibit shape characteristicsintended to interface with a specially designed deployment tool (e.g.,an applicator device). Such surface features can include flat surfaces,slots, grooves, notches, bevels, or other forms and can be on thecontact surface or body of the lateral section, the transition zonebetween the lateral section and the central section, within the body ofthe central section, or at the junction between two central sections incases of a bi-directional device.

FIGS. 12A-12D depict exemplary surface features. FIG. 12A includescross-sectional views A, B, and C comparing the contact component'scross-section to the fixation device's cross-section in places A, B, andC shown on the left-side of FIG. 12A. As depicted in cross-section A,the contact component's cross-section is circular and interrupted byopening 103. As depicted in cross-section B, the transition zone 111 hasa cross-section including flat surfaces parallel to the opening 103 forreceiving an applicator device 50. See FIG. 12B. As depicted incross-section C, the medial joint 109 has a circular cross-section thatis smaller than the contact component's cross-section. Exemplary surfacefeatures include flattened surfaces on the transition zone between thecentral and lateral sections of a bi-direction fixation device.

An exemplary applicator device 50 includes applicator guides 51 whichare essentially planar components that have a shape, as seen from abovethe plane, that has parallel flat edges of a size, shape, andorientation such that they can be advanced within the transition zone111 and around the transition zone 111. In this exemplary embodiment,the applicator device 50 includes two such applicator guides, and as theapplicator tool is advanced onto a bi-directional fixation device 100,each applicator guide interdigitates with the transition zone 111 ofeach component fixation device of the composite bi-directional fixationdevice 100. The applicator device 50 also exhibits two crimper arms 52that are between the two applicator guides (See upper portions of FIGS.12B and 12C) and move through a plane that is parallel to the two planesdefined by the applicator guides 51.

As the applicator device 50 is advanced onto the bi-directional fixationdevice 100, the fixation device 100 is held into a consistentorientation in relationship to the applicator device 50, with the commongroove, slot, or channel unhindered by the application device 50 suchthat it can be easily positioned in relation to a linear element. Thecrimper arms 52 (or other central section activating mechanism) areappropriately positioned and secured for deployment. As the crimper arms52 are activated, the central section is deformed and the linear elementis secured within the first fixation component 104 and the secondfixation component 108. The crimper arms 52 can also include cuttingelements that separate the two halves of the fixation device 100 and/orthe linear element. In addition, the shape of the transition zone 111and shape of either the applicator guides 51 or the crimper arms 52 maybe designed such that the crimper arms 52 deform the central sectionwhen activated and the length of portions of the transition zone 111 areincreased, thereby facilitating release of the applicator guides 51 fromthe transition zones 111.

FIGS. 13A-13G depict an exemplary method of using an exemplary fixationdevice 100 in accordance with the present invention. As depicted in FIG.13A, an exemplary bi-directional fixation device 100 can include asmooth transition between the contact and fixation components without amore narrow transition zone. As depicted, the fixation device receives alinear element 40 in a channel passing through the longitudinal lengthof the fixation device 100. FIGS. 13A-13G depict a method of using thefixation device 100 that is similar to that depicted in FIGS. 8A-10. Theupper and lower portions of the fixation device 100 may be separated bydeformation (e.g., using mechanical force), and/or heat. The linearelement 40 may be secured within the fixation device 100 by suchseparation, adhesives, or by other mechanisms.

FIGS. 14A-14E depict an exemplary method of using an exemplaryembodiment of a fixation device 100 and an exemplary embodiment of anapplicator device 50 in accordance with the present invention. Thetransition zone 111 between the central and lateral sections (i.e., thefixation components 104 and 108 and the contact components 101 and 105)of a component fixation device or of a bi-directional fixation devicecan provide advantages during both application and removal of thefixation device 100. In this embodiment, the applicator device 50includes crimper arms 52. The surfaces of the crimper arms 52 thatcontact the fixation device 100 include flat surfaces for compressionand elevated features for division of the bi-directional fixation device100 and the linear element 40 between the two fixation components 104and 108. The engagement of the central sections (i.e., the two fixationcomponents 104 and 108) with the compression surfaces of the applicatordevice 50 stabilize and secure the fixation device 100 and linearelement 40, while the cutting surfaces of the applicator device 50engage and cut through the medial joint 109.

As depicted in FIG. 14A, the fixation device 100 includes a firstcontact component 101 having a first contact surface 102 and firstopening 103 and a first fixation component 104. The fixation device 100also includes a second contact component 105 having a second contactsurface and second opening and a second fixation component 108. Thefirst fixation component 104 and the second fixation component 108 arejoined at medial joint 109 which is narrower than the fixationcomponents. The fixation components 104 and 108 are joined to eachrespective contact component 101 or 105 by transition zones 111 that arenarrower than the fixation components.

The linear element 40 may be placed in the fixation device's opening asdepicted in FIG. 14A. An end of the linear element 40 may be passedthrough a workpiece 70 as depicted in FIG. 14B and secured by anotherfixation device 100 as depicted in FIG. 14C. The applicator device 50 ispositioned over the fixation device 100 while tension is applied to thelinear element 40 as depicted in FIG. 14C. The applicator device isfurther activated by compressive forces as depicted in FIG. 14D tocompress the fixation components 104 and 108 around the linear element40 and cut the medial joint 109 and linear element 40. FIG. 14E depictsthe removal of the free section of the fixation device.

FIGS. 15A-15D depict exemplary methods of using an exemplary fixationdevice 100 and an exemplary removal tool 60 in accordance with thepresent invention. When fixation of a linear element 40 is limited tothe central section (i.e., the fixation component 104), and the lateralsection (i.e., the contact component 101) does not constrict or restrainthe linear element 40, separation of the central section can assist inrelease of the linear element 40 from the fixation device 100. Inexemplary embodiments where the central section remains intact afterseparation of the central and lateral sections, the linear element musttypically also be divided. In embodiments where complete or partialseparation of the central section from the lateral section releases thelinear element (i.e., the central section does not remain in thedeployed orientation), the released central section can be removed andlinear element fixation released without division of the linear element.

Removal of a fixation device can be assisted by a removal tool. Aremoval tool can take multiple forms. FIGS. 15A-15D depict an exemplaryremoval tool 60 has two arms 61 that are brought into approximation, andthe force of the approximation separates the central section from thelateral section. The space between the arms 61 could include acollection chamber such that the separated central section componentsare contained.

In another embodiment, the fixation device removal tool can be arectangular box (not shown) with a hole near one end. The hole istypically of sufficient size and shape to accommodate the centralsections of the fixation devices. The rectangular box typically alsoincludes a movable blade parallel to the longitudinal axis of theremoval tool configured such that the blade slides along a slot in theremoval tool and closes the hole in the removal tool. In practice, sucha removal tool would be positioned such that a central section of afixation device lies within the hole of the removal tool, and that asthe blade is advanced, the central section (and potentially thecontained linear element) are separated from the lateral section, andthe released central section is directed into the space within the boxof the removal tool.

FIGS. 16A-16E depict exemplary embodiments of a fixation device 100 inaccordance with the present invention. FIGS. 16B and 16C depict thecontact surfaces 102 and 106 of two contact components 101 and 105 oneither end of a bi-directional fixation device 100. As depicted by thedotted lines, the edges of the contact surfaces 102 may be removed tofacilitate position of the fixation device 100.

FIG. 16D depicts a fixation device 100 that includes two access openings110 in the fixation components 104 and 108. The access openings 110provide access to a linear element within the fixation device's channel.When the fixation device 100 is secured to a workpiece, the linearelement may be cut through the access opening 110 without increasing thetension on the linear element.

FIG. 16E depicts a fixation device 100 that includes transition zones111 and a medial joint 109 that are narrower than the fixationcomponents 104 and 108. These narrower portions of the fixation device100 can facilitate positioning of the fixation device 100 and securingof a linear element by, for example, interacting with an applicatordevice or removal tool.

Many variations in configuration of the components, zones, and joints ofthe fixation device can be employed to improve the function of thefixation device. For example, the margins of the lateral section canassume the shape of a circle, can be configured with a slot or groovewith beveled edges to assist in deployment or positioning, or can have achannel or groove which is offset, spiral, or asymmetric. Similarvariations can be employed in the transition zone, central section, orconnections between two central sections in bi-directional embodiments.The central sections and connecting sections can also be formed as tubeswith perforations, grooves, or holes, or may exhibit a wave-like orzig-zag configuration to improve linear element fixation strength.

FIG. 17A depicts a fixation device including contact components 101 and105 and fixation components 104 and 108. The fixation components 104 and108 include clips 113 that are closed around the fixation components 104and 108 and/or the linear element 40 between the contact components 101and 105 to secure the linear element 40.

FIG. 17B depicts a fixation device including contact components 101 and105 and fixation components 104 and 108 that are themselves clips. Thus,the fixation components 104 and 108 are not physically connected to thecontact components 101 and 105. The fixation components 104 and 108 mayalso include tabs, folds, or other surface features that may beinterfaced to assist in deployment or removal.

Off-set applicator tools such as that depicted in FIG. 4A can alter themechanism of fixation device deployment by introducing a fold or bend inaddition to compression of the central section. Fixation can be assistedby the presence of adhesives (e.g., pressure sensitive adhesives)incorporated into the central section or applied as a function of theapplicator tool.

FIG. 18A depicts an exemplary fixation device 100 including a contactcomponent 101 having an opening 103. A linear element is secured in theexemplary fixation device 100 by a fixation component that is notphysically connected to the contact component 101.

FIGS. 18B-18D depict an exemplary fixation device 100 that includes acontact component 101 and an interlocking fixation component 104. In apre-loading state depicted in FIGS. 18B and 18C, the fixation component104 includes an opening for receiving a linear element that is slightlynarrower than the contact component's opening 103 (i.e., W is greaterthan W⁺). A user places linear element 40 in the fixation device 100 andactivates the fixation device (e.g., by pressing together the fixationdevice's sides as defined by the opening manually or using an applicatordevice). The sides of the fixation component 104 as defined by theopening interlock to securely hold the linear element 40. The fixationcomponent 104 or the contact component 101 may include an accessoryfixation structure (e.g., a locking pin) to help secure the fixationdevice 100 after deformation.

The fixation device can be configured with many different profiles tofit specific functions. In addition, the device can be deformed from amanufactured state (rest state), to a “pre-tensioned” deployment state,that upon transition of different sections becomes interlocking, forexample transitioning from a spiral to a disc-like configuration. FIGS.20A-20C depict an exemplary fixation device 100 that transitions from aspiral to a disc-like configuration. Either the central section or thelateral section can demonstrate components that interface or interlockto assist in device function, maintenance of the security of the linearelement, of removal.

FIGS. 19A-19D depict exemplary fixation devices 100 and interlockingfeatures. As depicted in FIG. 19A, the contact components 101 and 105,transition zones 111, fixation components 104 and 108, and medial joint109 all include interlocking elements. FIGS. 19B and 19C depict close-upviews of exemplary interlocking elements that include curved surfaces,notches, and hooks that engage each other.

FIG. 19D depicts another exemplary fixation device 100 includinginterlocking elements as secured to a linear element 40. The fixationdevice's interlocking elements may be on the interior interlockingsurfaces of the fixation device 100 and/or may have exterior contoursthat match the exterior surface of the fixation device 100. FIG. 19Edepicts an exemplary interlocking element including a latch or pin thatengages a slot or hook. FIG. 19F depicts another exemplary interlockingelement including a latch or pin that engages a slot or hook.

Exemplary fixation devices can include specific curves, notches,grooves, pins, slots, waves or other surface features within thereceiving channel, slot, or groove to assist in secure fixation of thecontained linear element at deployment.

FIGS. 20A-20C depict an exemplary embodiment of a fixation device 100 inaccordance with the present invention. The fixation device's opening 103has been depicted as a relatively large opening as compared to the outercircumference of the fixation device 100 to facilitate the demonstrationof the function of the fixation device 100. Typically, the opening 103has a much smaller circumference as compared to the outer circumferenceof the fixation device 100.

The fixation device 100 can be manufactured such that the lateralsection (i.e., the contact component) is non-planar in a state of rest(natural state) as in FIG. 20A, with the spiral representing a greaterthan 360 degree rotation. In this embodiment, the edges of the lateralsection that represent the borders of the common groove do not lie inthe same horizontal plane at right angles to the axis of the device.Similarly the portions of the central section lie in differenthorizontal planes in relationship to the axis of the fixation device.Deployment of the device involves the application of a pre-deploymentdeforming (“pre-loading”) force that increases the radius of the lateralsection from a top view and flattens the lateral section such that thesides of the linear element-receiving groove are brought into similarplanes in relationship to the longitudinal axis of the device asdepicted in FIG. 20B. This pre-tensioning force imparts a stress withinthe body of the lateral section. A linear element is then positionedwithin the now visible common channel, and the deforming, pre-loadingforce is released such that the lateral sections and central sectionsare interlocked as in FIG. 20C. Because the imparted stress upon thelateral section is only partially released with device deployment, thestress provides an ongoing force approximating the central section andsecuring the linear element. Reversal of the deployment sequence removesthe fixation device. Ridges, grooves, slots, or other features may beincluded to guide the movement from a natural “at rest” state to apre-deployment (pre-tensioned) state or from the pre-deployment(pre-tensioned) state to a deployment state, or similarly to aid thereverse process (fixation device removal).

FIGS. 20D and 20E depict an exemplary fixation device 100 including acontact component 101 and fixation component 104 that function in thesame manner as the fixation device depicted in FIGS. 20A-20C. In thisregard, FIG. 20D depicts the exemplary fixation device 100 in a statecorresponding to that of FIG. 20B. A linear element 40 is placed in thefixation device's opening which is visible in FIG. 20D. The pre-loadingforce is then released such that the fixation device 100 closes aroundthe linear element 40 as in FIG. 20E.

FIGS. 21A-21D depict an exemplary fixation device 100 and an exemplaryapplicator device 50. The fixation device 100 includes a contactcomponent 101 having a contact surface 102 and an opening 103. Thecontact component 101 has tapered walls with receiving threads thatdefine the opening 103. The fixation device 100 also includes a fixationcomponent 104 (e.g., a hollow screw). The fixation component 104includes a channel 114 and threads that engage the receiving threads ofthe contact component 101. As depicted in FIG. 21B, the contactcomponent's tapered walls and the fixation component's channel 114include a gap to facilitate placement of a linear element.

FIG. 21C depicts a linear element 40 loaded into the fixation device 100and applicator device 50. The applicator device 50 includes a slot 53(e.g., a slot, groove, notch, hole, channel, star-drive) to accommodatethe linear element 40 without impinging, dividing, or damaging thelinear element 40. The tip of the applicator device 50 engages thefixation component 104 (e.g., via a Phillips-head screw interface asdepicted). When a rotational force is applied to the applicator device50, the fixation component 104 is threaded more deeply into the contactcomponent 101. Typically, at least the lower portion of the fixationcomponent 104 is a slightly deformable material. As the fixationcomponent 104 is driven into the contact component 101, at least thelower portion of the fixation component 104 deforms to close around thelinear element 40 (i.e., the channel 114 shrink as the fixationcomponent 104 is compressed).

The fixation component 104 can be in two or more portions or can exhibitslots or grooves such that the channel 114 is more efficientlycompressed (advanced centrally) as rotational motion is imparted. Thefixation component 104 can also be connected to the contact component101 with deformable transition zone elements that can twist and reducethe diameter of the common channel, slot, or groove. The fixationcomponent 104 may exhibit posts, tabs, or other features that interlockwith the contact component 101 when the fixation component 104 isrotated in relationship to the contact component 101. In each of theseembodiments, reversal of the rotational force releases the fixed linearelement.

FIGS. 22A-22D depict exemplary fixation devices 100 including contactcomponents 101 and fixation components 104. The contact components 101have an opening 103. The fixation components 104 each include a channel114 and a T-shaped post 115, and the openings 103 are shaped to receivethe T-shaped post 115 at only particular orientations. The contactcomponent's opening 103 in FIGS. 22C and 22D also extends to the outeredge of the contact component 101. FIG. 22B depicts a bottom view of thefixation components 104.

A linear element may be passed through the opening 103 and into thechannel 114. As depicted in FIG. 22A, the fixation component 104 and itsT-shaped post 115 are aligned with and inserted into the opening 103.The fixation component 104 may be rotated within the contact component101 to align the opening 103 and channel 114 as depicted in the overheadview of FIG. 22C. A linear element 40 may then be provided in theopening 103 and channel 114. The fixation component 104 is rotatedwithin the contact component 101 to secure the linear element 40 asdepicted in FIG. 22D. The contact component 101 and fixation component104 may be provided with additional features, such as ramps, tabs,and/or posts, that interact with the T-shaped post 115 to increase theforce applied to the linear element when the fixation component 104 isrotated within the contact component 101.

FIGS. 23A-23D depict an exemplary fixation device and an exemplaryapplicator device 50 in accordance with the present invention. Thefixation device 100 includes a contact component 101, a fixationcomponent 104, and a transition zone 111. The surface contours of boththe transition zone 111 and the fixation component 104 can facilitateboth deployment of the fixation device 100 and removal of the fixationdevice 100. In this embodiment, the transition zone 111 has two parallelflat surfaces on opposite sides as shown by the dotted lines in FIG.23A. The fixation component 104 has a hexagonal shape as seen from thetop view. Separation of the fixation component 104 from the contactcomponent 101 can be accomplished by turning or twisting the fixationcomponent 104 around an axis defined by a common channel 114 (e.g., aslot or groove) of the fixation device 100. The flat surfaces of thefixation device 100 interact with an applicator device 50 that may alsoserve as a removal tool.

Although hexagonal shapes and parallel surfaces have been described,other shape variations are within the scope of the present invention.For example, the fixation component 104 may include two parallel flatsurfaces rather than a hexagonal shape. The contact component 101 mayalso include similar contour features such as flat surfaces, holes,slots, grooves, or notches to help facilitate removal. In addition, acommon slot or groove in the lateral section can function as a point ofstabilization with a removal tool.

Any two of the three sections (i.e., the contact component 101, thetransition zone 111, and/or the fixation component 104) can be engagedto separate the fixation component 104 from the contact component 101 inthis manner. For example, the applicator device 50 may engage thecontact component 101 and the transition zone 111, the contact component101 and the fixation component 104, or the transition zone 111 and thefixation component 104 for this purpose.

Exemplary Embodiments

[1]. A fixation device for securing a linear element extending through aperforation in a work-piece, said fixation device comprising:

a. a base section having a contact surface on one end shaped to engage awork-piece;

b. an apical (central) section opposite the contact surface of the basesection; and

c. a groove, slot, channel, or receiving contour so shaped as toaccommodate a linear element, said groove, slot, channel, or receivingcontour extending at a minimum through the base section and into theapical section;

d. said groove, slot, channel, or receiving contour at a pre-deploymentrest state defining the longitudinal axis of the fixation device;

said fixation device being so constructed as to be deformable such thatsaid deformation will constrict the space within said groove, slot,channel, or receiving contour thereby securing a linear element which ispositioned within said groove, slot, channel, or receiving contour atthe time of deformational deployment;

so constructed such that a force vector applied a linear element thussecured will engage the fixation device to the work-piece when saidlinear element extends through a work-piece and the force vector is inthe direction of said work-piece.

[2]. A fixation device for securing a linear element extending through aperforation in a work-piece, said fixation device comprising:

a. a base section having a contact surface on one end shaped to engage awork-piece after deformation of said fixation device, said based sectionhaving a non-planar orientation at rest state with overlapping surfacesin relationship to the longitudinal axis of the device;

b. an apical section opposite the contact surface of the contactsection; and

c. a groove, slot, channel, or receiving contour so shaped as toaccommodate a linear element after partial deformation of said device;said groove, slot, channel, or receiving contour extending through bothbase section and apical section at such time as the device is partiallydeformed;

d. said groove, slot, channel, or receiving contour at said partiallydeformed state defining the longitudinal axis of the fixation device;

said fixation device being so constructed that with completion ofdeformation said overlapping surfaces can be transposed in relationshipto the longitudinal axis of said fixation device such that saiddeformation and transposition secure a linear element which ispositioned within the groove, slot, channel, or receiving contour of thefixation device at the time of partial deformation;

so constructed such that a force vector applied a linear element thussecured will engage the fixation device to the work-piece when saidlinear element extends through a work-piece and the force vector is inthe direction of said work-piece.

[3]. A fixation device for securing a linear element extending through aperforation in a work-piece, said fixation device comprising:

a. a base section having a contact surface on one end shaped to engage awork-piece;

b. an apical section opposite the contact surface of the contactsection, said apical section exhibiting a non-planar orientation at reststate with overlapping surfaces in relationship to the longitudinal axisof the device; and

c. a groove, slot, channel, or receiving contour so shaped as toaccommodate a linear element after partial deformation of said device;said groove, slot, channel, or receiving contour extending through bothbase section and apical section at such time as the device is partiallydeformed;

d. said groove, slot, channel, or receiving contour at said partiallydeformed state defining the longitudinal axis of the fixation device;

said fixation device being so constructed that with completion ofdeformation said overlapping surfaces can be transposed in relationshipto the longitudinal axis of said fixation device such that saiddeformation and transposition secure a linear element which ispositioned within the groove, slot, channel, or receiving contour of thefixation device at the time of partial deformation;

so constructed such that a force vector applied a linear element thussecured will engage the fixation device to the work-piece when saidlinear element extends through a work-piece and the force vector is inthe direction of said work-piece.

[4]. A double fixation device exhibiting two fixation devices as in (1),(2), or (3) wherein;

a. said individual fixation devices are connected at the apical terminusof each device such that the grooves, slots, channels, or receivingcontours so shaped as to accommodate a linear element within eachindividual fixation device are aligned to create a common groove, slot,channel, or receiving contour along the entirety of said double fixationdevice; and

b. each individual fixation device is separately deployable, eithersimultaneously or in series, while a common linear element is positionedwithin the common groove, slot, channel, or receiving contour;

c. with said connection between individual fixation devices beingdivisible so as to create two independently functioning fixation devicesafter deformational deployment and separation.

[5]. A fixation device as in [1-4] constructed of a malleable materialsuch that the deploying deformation may be induced by means of amechanical force applied to the fixation device.

[6]. A fixation device as in [1-4] constructed of a material such thatdeformation may be facilitated by the application of heat, ultrasound,or other energy source.

[7]. A fixation device as in [1-4] wherein deformation is accomplishedby means of bending or folding.

[8]. A fixation device as in [1] or [4] wherein the apical segments canbe folded into a channel within the base segment.

[9]. A fixation device as in [1-4] where the device exhibits interactivepins, slots, tabs, grooves, notches, or other surface contour featureswhich can interact to stabilize the deployment state.

[10]. A fixation device as in [1-4] which exhibits an adhesive layer onat least one surface of the device.

[11]. A fixation device as in [1-4] which exhibits a transition zonebetween a base section and an apical section, and

a. separation of the base section and apical section at said transitionzone can be accomplished by cutting, compressing, distorting, twisting,heating, breaking, or other means; and

b. said separation of base and apical sections releasing theconstriction of the groove, slot, channel, or receiving contour whichsecures the contained linear element allowing separation of the linearelement from the deployed fixation device.

[12]. A fixation device as in [1-4] wherein the apical section or atransition zone between the apical section and base section can bedeformed by means of a malleable clip which remains attached to thefixation device during deployment.

[13]. A fixation device as in [1-4] with a secondary surface groove,slot, channel, notch, or other surface contour which allows access tothe secured linear device within said fixation device after deployment.

[14]. A device as in [1-4] that exhibits ridges, grooves, shelves,threads, adhesive layer or other surface features within the commonchannel to assist in securing of a linear element.

[15]. A device as in [1-4] that exhibits slots, grooves, holes, bevels,flattened surfaces, or other surface characteristics to assist in devicedeployment or removal.

[16]. A device as in [1-4] wherein the fixation section exhibits tabs,wings, flanges, or other surface features which can be used tosecondarily adjust or to release a contained linear element.

[17]. A device as in [1] and [2] wherein the base plate or fixationsection exhibit holes, perforations, channels or other surface features.

[18]. A device as in [1-4] wherein the base plate and/or fixationsection exhibits holes, perforations, channels or other surfacefeatures; and

a. said holes, perforations, channels or other surface features can beutilized to fix the base section to a work-piece;

b. said fixation of the base section to a work-piece being accomplishedby various means including adhesion, suturing, sewing, pins, screws, orother mechanisms, such that

c. once deployed to secure a linear element and fixed to the work-piecethrough which said linear element emerges, said linear element issecured to force vectors both toward the work-piece and away from thework-piece.

[19]. A device as in [1-4] that exhibits color variation.

[20]. A storage container for devices as in [1-4], said storagecontainer exhibiting slots, grooves, notches or other surface featuresso configured as to hold said devices in orientation for loading onto anapplicator.

[21]. An applicator for a device as in [1-4], said applicator allowingindividual loading and deployment of said fixation device.

[22]. An applicator for a device as in [1-4], said applicator allowingloading and deployment of multiple said fixation devices.

[23]. An applicator for a device as in [1-4], said applicator exhibitingwaves, grooves, or other surface features along the section where thefixation device is loaded into said applicator, with said waves,grooves, or other surface features producing a non-uniform deformationof the fixation device.

[24]. An applicator for a device as in [1-4], said applicatorsimultaneously exhibiting both a compressive surface and a cuttingsurface.

[25]. An applicator for a device as in [1-4], said applicator exhibitingbidirectional compressive surfaces and/or cutting surfaces.

[26]. An applicator for a device as in [1] and [2].

[27]. A device as in [1] and [2] wherein the device is symmetrical whenrotated about an axis defined by the center of the common channel.

[28]. A device as in [1] and [2] wherein the base plate has anon-uniform radius when rotated about an axis defined by the center ofthe common channel.

[29]. A device as in [1] and [2] wherein the central fixation sectionhas a non-symmetrical radius when rotated about an axis defined by thecenter of the common channel.

[30]. A device as in [1] and [2] wherein the device exhibits a slot orgroove which extends from a lateral surface of a base plate to thecommon channel.

[31]. A device as in [1] and [2] wherein the device exhibits a slot orgroove which extends from a side of a central fixation section to thecommon channel.

Exemplary Embodiments

[1]. A device comprising a base plate which exhibits an essentially flatsurface on one side;

said base plate connected to a central fixation section on a side of thebase plate opposite to said essentially flat surface;

said combined base plate and central fixation section containing acommon channel or pathway which allows the positioning of a linearelement through both base plate and central fixation section;

wherein the central fixation section can be purposefully deformed, suchdeformation causing a subsequent change in configuration of the commonchannel.

[2]. A device comprising two base plates, each of which exhibits anessentially flat surface on one side;

said base plates each connected to a central fixation segment on a sideof the base plate opposite to the flat surface;

with said central fixation sections connected at the portion of thecentral fixation section opposite to the essentially flat surfaces ofthe base plates;

said base plates and central fixation sections containing a commonchannel or pathway which allows the positioning of a linear elementthrough both base plates and both central fixation sections;

wherein both central fixation sections can be purposefully deformed,such deformation causing a subsequent change in configuration of thecommon channel.

[3]. A device as in [1] and [2] wherein the device is symmetrical whenrotated about an axis defined by the center of the common channel.

[4]. A device as in [1] and [2] wherein the base plate has a non-uniformradius when rotated about an axis defined by the center of the commonchannel.

[5]. A device as in [1] and [2] wherein the central fixation section hasa non-symmetrical radius when rotated about an axis defined by thecenter of the common channel.

[6]. A device as in [1] and [2] wherein a central fixation sectionexhibits a narrowing near the junction of said central fixation sectionwith the base plate to which it is directly connected.

[7]. A device as in [1] and [2] wherein a central fixation sectionexhibits a narrowing near the terminus of the central section notconnected directly to a base plate.

[8]. A device as in [1] and [2] wherein the device exhibits a slot orgroove which extends from a lateral surface of a base plate to thecommon channel.

[9]. A device as in [1] and [2] wherein the device exhibits a slot orgroove which extends from a side of a central fixation section to thecommon channel.

[10]. A device as in [1] and [2] that exhibits an adhesive layer appliedto the common channel.

[11]. A device as in [1] and [2] that exhibits ridges, grooves, shelves,threads, or other textural features within the common channel.

[12]. A device as in [1] and [2] that exhibits color variations toassist in orientation or removal.

[13]. A device as in [1] and [2] that exhibits slots, grooves, holes,bevels, flattened surfaces, or other surface characteristics to assistin device placement or removal.

[14]. A device as in [1] and [2] wherein the fixation channel can bedeformed by the application of a compressive force.

[15]. A device as in [1] and [2] wherein the fixation channel can bedeformed by the controlled application of heat.

[16]. A device as in [1] and [2] wherein the fixation section exhibitstabs, wings, flanges, or other surface features which can be used tosecondarily modify the fixation section in order to release a containedlinear element.

[17]. A device as in [1] and [2] wherein once a deformed central sectionand the connected base plate can be separated by cutting, compressing,distorting, twisting, melting, breaking, or other means.

[18]. A device as in [1] and [2] wherein the base plate or fixationsection exhibit holes or perforations.

[19]. A device as in [2] that exhibits a color difference betweenopposite fixation sections or base plates.

[20]. A device as in [2] that exhibits asymmetry along the longitudinalaxis.

[21]. An applicator for a device as in [1] and [2], said applicator soshaped as to deform the fixation section in a uniform manner.

[22]. An applicator for a device as in [1] and [2], said applicator soshaped as to deform the fixation section in a non-uniform manner.

[23]. An applicator for a device as in [1] and [2], said applicatorexhibiting a cutting surface so positioned as to align with the terminusof a fixation section opposite to the essentially flat surface of a baseplate.

[24]. An applicator for a device as in [1] and [2], said applicatorsimultaneously exhibiting both a compressive surface and a cuttingsurface.

[25]. An applicator for a device as in [1] and [2].

[26]. A storage container for devices as in [1] and [2], said storagecontainer exhibiting slots, grooves, notches or other surface featuresso configured as to hold said devices in orientation for loading onto anapplicator.

[27]. A multi-load applicator capable of holding two or more devices asin [1] and/or [2] such that said common channels or pathways of saiddevices are parallel.

[28]. A multi-load applicator capable of holding two or more devices asin [1] and/or [2] such that said common channels or pathways of saiddevices are aligned along a single axis.

To supplement the present disclosure, this application incorporatesentirely by reference the following commonly assigned patent applicationpublications, and patent applications: International Patent ApplicationPublication No. WO 2012/135735 for a Force Modulating Tissue Bridge(Eaves); U.S. Patent Application No. 61/469,966 for aPre-Tensioned/Pre-Stressed Device, filed Mar. 31, 2011 (Eaves); U.S.Patent Application No. 61/470,158 for a Device and Method for Applying aPre-Tensioned Element to Opposing Surfaces, filed Mar. 31, 2011 (Eaves);International Patent Application Publication No. WO 2013/059600 for aRemovable Covering and Interactive Packaging (Eaves); U.S. PatentApplication No. 61/654,748 for a Removable Covering and InteractivePackaging, filed Jun. 1, 2012 (Eaves); U.S. Patent Application No.61/549,317 for a Protective Covering for Adhesive Backed Articles andMethods of Applying the Same, filed Oct. 20, 2011 (Eaves); and U.S.Patent Application No. 61/561,522 for a Protective Packaging forAdhesive Backed Articles, filed Nov. 18, 2011 (Eaves).

In the specification and/or figures, typical embodiments of theinvention have been disclosed. The present invention is not limited tosuch exemplary embodiments. The use of the term “and/or” includes anyand all combinations of one or more of the associated listed items. Thefigures are schematic representations and so are not necessarily drawnto scale. Unless otherwise noted, specific terms have been used in ageneric and descriptive sense and not for purposes of limitation.

The invention claimed is:
 1. A method of at least securing a linearelement to first and second fixation devices, comprising: having thefirst and second fixation devices in a first configuration, wherein eachof the first and second fixation devices comprises a fixation componentconnected to a contact component, and in the first configuration thefixation components are positioned between the contact components; andthen providing a second configuration, comprising: securing first andsecond portions of the linear element respectively to the fixationcomponents, arranging the linear element so that third and fourthportions of the linear element respectively extend from the first andsecond portions of the linear element, and separating the first andsecond portions of the linear element from one another, wherein thelinear element is a suture strand.
 2. The method according to claim 1,wherein: in the first configuration, the fixation components areconnected to one another; and the method comprises separating thefixation components from one another.
 3. The method according to claim2, comprising simultaneous occurrence of: the separating of the firstand second portions of the suture strand from one another, and theseparating of the fixation components from one another.
 4. The methodaccording to claim 2, comprising simultaneous occurrence of: thesecuring of the first and second portions of the suture strandrespectively to the fixation components, and the separating of the firstand second portions of the suture strand from one another, and theseparating of the fixation components from one another.
 5. The methodaccording to claim 1, wherein the contact component of the firstfixation device comprises a contact surface configured to engage aworkpiece, and the contact surface is positioned oppositely from thefixation component of the first fixation device.
 6. The method accordingto claim 1, wherein the securing of the first and second portions of thesuture strand respectively to the fixation components is comprised of:securing the first portion of the suture strand in a first fixationcomponent of the fixation components, and securing the second portion ofthe suture strand in a second fixation component of the fixationcomponents.
 7. The method according to claim 1, wherein the securing ofthe first and second portions of the suture strand respectively to thefixation components is comprised of simultaneously: securing the firstportion of the suture strand to a first fixation component of thefixation components, and securing the second portion of the suturestrand to a second fixation component of the fixation components.
 8. Themethod according to claim 1, comprising: arranging a portion of thethird portion of the suture strand in an opening of the contactcomponent of the first fixation device; and arranging a portion of thefourth portion of the suture strand in an opening of the contactcomponent of the second fixation device.
 9. The method according toclaim 1, wherein the securing of the first and second portions of thesuture strand respectively to the fixation components is comprised ofdeforming the fixation components.
 10. The method according to claim 9,wherein the deforming comprises at least one applying selected from thegroup consisting of: applying mechanical force to the fixationcomponents, applying heat to the fixation components, applyingultrasonic energy to the fixation components, and/or applying light tothe fixation components.
 11. The method according to claim 1, furthercomprising engaging the first fixation device against a workpiece sothat the contact component of the first fixation device is positionedbetween the workpiece and the fixation component of the first fixationdevice.
 12. The method according to claim 11, wherein the engagingoccurs prior to the separating of the first and second portions of thesuture strand from one another.
 13. A method of at least securing alinear element to first and second fixation devices, comprising: havingthe first and second fixation devices in a first configuration, whereineach of the first and second fixation devices comprises a fixationcomponent connected to a contact component, and in the firstconfiguration the fixation components are positioned between the contactcomponents; and then providing a second configuration, comprising:securing first and second portions of the linear element respectively tothe fixation components, arranging the linear element so that third andfourth portions of the linear element respectively extend from the firstand second portions of the linear element, and separating the first andsecond portions of the linear element from one another, wherein thesecuring of the first and second portions of the linear elementrespectively to the fixation components is comprised of adhering withadhesive material.
 14. The method according to claim 13, wherein thelinear element is a suture strand.
 15. A method of at least securing alinear element to first and second fixation devices, comprising: havingthe first and second fixation devices in a first configuration, whereineach of the first and second fixation devices comprises a fixationcomponent connected to a contact component, and in the firstconfiguration the fixation components are positioned between the contactcomponents; then providing a second configuration, comprising: securingfirst and second portions of the linear element respectively to thefixation components, arranging the linear element so that third andfourth portions of the linear element respectively extend from the firstand second portions of the linear element, and separating the first andsecond portions of the linear element from one another; passing thefirst, second, and third portions of the linear element through aworkpiece so that at least a portion of the fourth portion of the linearelement is positioned in the workpiece; and engaging the contactcomponent of the second fixation device against the workpiece prior tothe separating of the first and second portions of the linear elementfrom one another, and wherein the workpiece comprises tissue associatedwith a wound.
 16. The method according to claim 15, further comprising:passing at least a portion of the third portion of the linear elementthrough the workpiece; and engaging the contact component of the firstfixation device against the workpiece.
 17. The method according to claim16, comprising applying tension to the third portion of the linearelement.
 18. The method according to claim 17, wherein the engaging ofthe contact component of the first fixation device is responsive to thetensioning.
 19. A method of at least securing a linear element to firstand second fixation devices, comprising: having an article comprisingboth of the first and second fixation devices in a connected-togetherconfiguration, wherein: the article comprises a middle sectionpositioned between, and connected to each of, first and second lateralsections, the middle section comprises first and second fixationcomponents that are connected to one another in the connected-togetherconfiguration, the first fixation device comprises the first fixationcomponent connected to the first lateral section, and the secondfixation device comprises the second fixation component connected to thesecond lateral section; and then providing a second configuration,comprising: securing first and second portions of the linear elementrespectively to the first and second fixation components, arranging thelinear element so that third and fourth portions of the linear elementrespectively extend from the first and second portions of the linearelement, separating the first and second fixation components from oneanother, and separating the first and second portions of the linearelement from one another, wherein the linear element is a suture strand.20. The method according to claim 19, comprising simultaneous occurrenceof: the securing of the first and second portions of the suture strandrespectively to the first and second fixation components, and theseparating of the first and second portions of the suture strand fromone another, and the separating of the first and second fixationcomponents from one another.
 21. The method according to claim 19,further comprising engaging the first fixation device against aworkpiece so that the first lateral section is positioned between theworkpiece and the first fixation component.
 22. The method according toclaim 21, wherein the engaging occurs prior to both: the separating ofthe first and second portions of the suture strand from one another, andthe separating of the first and second fixation components from oneanother.
 23. A method of at least securing a linear element to first andsecond fixation devices, comprising: having an article comprising bothof the first and second fixation devices in a connected-togetherconfiguration, wherein: the article comprises a middle sectionpositioned between, and connected to each of, first and second lateralsections, the middle section comprises first and second fixationcomponents that are connected to one another in the connected-togetherconfiguration, the first fixation device comprises the first fixationcomponent connected to the first lateral section, and the secondfixation device comprises the second fixation component connected to thesecond lateral section; then providing a second configuration,comprising: securing first and second portions of the linear elementrespectively to the first and second fixation components, arranging thelinear element so that third and fourth portions of the linear elementrespectively extend from the first and second portions of the linearelement, separating the first and second fixation components from oneanother, and separating the first and second portions of the linearelement from one another; passing the first, second, and third portionsof the linear element through a workpiece so that at least a portion ofthe fourth portion of the linear element is positioned in the workpiece;and engaging the second lateral section against the workpiece prior to:the separating of the first and second portions of the linear elementfrom one another, and the separating of the first and second fixationcomponents from one another; wherein the workpiece comprises tissueassociated with a wound.
 24. The method according to claim 23, furthercomprising: passing at least a portion of the third portion of thelinear element through the workpiece; and engaging the first lateralsection against the workpiece.